Recent years have seen a mass of innovation in medical devices. UBM’s annual Pharmapack exhibition, which returned to Paris in early February, saw many such innovations on show, some of them for the first time at an event. Many of these were on show at the dedicated Innovation Gallery.
The technical details of these devices vary considerably but they are generally driven by similar trends: improving patient compliance and reducing the possibility of error, particularly for self-administration drugs; simplicity of use: flexibility of configuration of dose values; addressing the challenges of biologicals; connectivity; and, perhaps above all, the move to personalized medicine and away from one-size-fits-all solutions.
From French firm Nemera came the Safelia range of 1 ml and 2.25 ml two-step autoinjector platforms. They were designed, according to Strategy Director Isabelle Delcroix, to handle all kinds of liquid formulations, especially highly viscous formulations of up to 1,000 cP, while also trying to improve the patient experience by reducing needle gauge and injection time, slowing needle penetration and reducing pain.
The patented design includes the ability to handle high injection spring forces and deliver the formulations in standard glass syringes. The autoinjectors are held by the shoulder rather than the structurally weaker flanges, allowing spring forces of up to 70 N with standard plastic parts. A rotating cam system absorbs spring release shock and energy, ultimately reducing the risk of breakage during firing.
“Safelia is a fully intuitive two-step process for patient: remove the cap, then press onto injection site,” she added. Insertion and retraction are automatic and the insertion speed of the syringe can be varied during the process: penetration can be slowed down inside body tissues, pressure peaks inside the tissues are limited and retraction is delayed to allow enough time to absorb the drug. However, despite all the flexibility, the patient cannot adjust the dose.
Haselmeier, a Stuttgart-based specialist in self-injection devices, was showing D-Flex, its flexible disposable pen for manual injection, for the first time at a show. This had already won an award from ‘Good Design’ for design excellence in 2016, although it not been officially announced to the market at the time.
The D-Flex is designed to close the gap in the 3 ml cartridge market between fixed dose pens and variable-dose pens where the dose can be finely adjusted by the patient. It can be configured for several fixed doses which can be selected during assembly, but the system prevents patient error by using a dial system set only to the allowed doses.
“Imagine you have one or several fixed dose pens for various applications.” said Stefan Gaul, Strategic Product Manager at Haselmeier. “D-Flex gives you a unique pen with all the required pre-set doses and a prevention mechanism for unintended doses that is not available with standard pre-set injection devices — hence the marketing slogan ‘It takes just one’.”
Biocorp, a French maker of medical devices, showcased the Newgard passive safe system, an integrated passive safety system for prefilled syringes that is compatible with standard nests and tubs and with 0.5 or 1 ml syringes. A functional prototype is currently at the pre-operational stage.
A company executive said: “Newgard is fully transparent for operation, so it can add value to products. The safety system is already integrated by us. You can also integrate it into a reconstitution system with other connected devices, which helps to improve patient adherence, and it can be directly connected to apps where we can store data in a closed system.”
Connectivity is to the fore in the Enya platform, which was developed by Irish firm Innovation Zed and launched in a joint venture with the SHL Group, a manufacturer of injection devices. This is described as a smart add-on range of devices for injection pens across multiple conditions.
John Hughes, CEO of Innovation Zed, noted that the scale of chronic conditions treated by self-injection – such as multiple sclerosis, diabetes and Parkinson’s disease - is rising rapidly. The economic value of data on the behaviour of injectables is “dramatic” for both patients and payers, he said, but adding connectivity to injectables has always been very expensive.
“Enya is a totally separate add-on that can be attached or integrated at the manufacturing stage. It produces data from the pen that is interpreted by condition management software as every condition has different challenges and thus different management challenges. Enya is already on the market and is being used to manage diabetes data,” Hughes said.
A device is attached to an injection pen and watches the user as he injects, puts it away and measures the dose. It can be customised, as pharma companies will want to want to add their own functionality to the platform. “As well as the date, time and dose, it can record the temperature of the insulin and even the location of the pen when it was used,” said Hughes.